Whistleblowing 101

I hate that word "whistleblowing". However here is a rapid pictorial guide to asking questions while preserving your sanity.



Lesson 1: Ignore those many institutions whose sole apparent remit is to hide problems on behalf of powerful friends. It is not the best of times for institutions that have claimed the right to uphold standards of integrity in medicine. In the UK, the General Medical Council (GMC), the Medicines and Healthcare Products Regulatory Authority (MHRA), the UK Panel for Research Integrity and Public Concern at Work are examples of organizations that are having trouble working out what they are for. Just state the obvious and let the obfuscators obfuscate.

As Groucho Marx said of the MHRA and research fraud:

"Either it is dead or my watch has stopped".

Or as George Orwell said of the General Medical Council:

"We have now sunk to a depth where the restatement of the obvious is the first duty of intelligent men".

How about this as a statement of the obvious: "Research fraud is not generally a good thing in medicine".

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The Contract (Procter and Gamble)

In 2002 I signed a research agreement with Procter and Gamble Pharmaceuticals [1]. Research was to be carried out at the University of Sheffield by two named investigators (Dr Aubrey Blumsohn, Professor Richard Eastell).

It is accepted that a University would be guilty of negligence in permitting investigators to sign a contract prohibiting or hindering release of information involving a drug [2,3]. Industry cannot buy the right to desired findings or the right to suppress undesired findings. The agreement signed[1] was however in accordance with good practice, and should have protected integrity:

• The agreement did not seek to impose restrictive limitations on the rights and obligation of investigators with regard to data [1 section 4.3]. It specified that the university clinical investigators would interpret and report upon the data.
• The agreement did not seek to impose restrictive conditions on honest unfettered publication [1 section 4.3]. The contract stated that sponsor should be given courtesy of sight of any proposed publication, but specified that investigators were under no obligation to incorporate any comment from the sponsor.
• The agreement imported the obligations placed on academics by the University itself, the policies of the University, and obligations imposed by professional rules of conduct [1 section 1.2]. It stated - "The institution through its policies and practices" should cause the investigators to observe "all responsibilities" as "employees of the University of Sheffield". The University of Sheffield in turn has clear guidance pertaining to research integrity and professional obligations (See Sheffield University Research Integrity Guidelines).

References

1. Research Agreement between P&G Pharmaceuticals, Dr A Blumsohn and Professor R Eastell. The University of Sheffield (2002-06-02).
2. Steinbrook, Robert (2005-05-26). "Gag clauses in clinical-trial agreements". The New England journal of medicine 352 (21): 2160-2. PMID 15917381.
3. Mello, Michelle M; Brian R Clarridge, David M Studdert (2005-05-26). "Academic medical centers' standards for clinical-trial agreements with industry". The New England journal of medicine 352 (21): 2202-10. PMID 15917385.

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Telling it like it is (Procter and Gamble)

Not sure how I missed this one. From the Center for Media and Democracy (prwatch.org) 25 March 2008.

The director of external relations for Procter & Gamble, Mark Chakravarty, recently told a UK healthcare PR conference that the drug industry is less than popular with the public. "There is a high suspicion of the pharma industry. Greed, dishonesty and fraud are some of its associations. The clinical trial press this week and an increased number of drug scandals add to this image," he said.

Quite, Procter and Gamble.

I'm less worried about the "greed". Commercial companies don't need to apologise for generating money from honest science and real innovation. Let's concentrate on the lies and the fraud, and more importantly on the collusion with government and "regulators" to hide evidence, to excuse bad science and to escape responsibility. Why not give me a call Mr Chakravarty? Effective public relations requires working with critics, admitting faults and correcting them.



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Those with unbitten hands

Dont bite ..... the hand that feeds you


And the corollary is .... if the hand is unbitten, look at who it feeds.

Lick the hand.

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Money and accountability (Procter and Gamble)

My ex colleagues at Sheffield University are in receipt of a great deal of new grant money. That is good. I am pleased. However, with greatness comes the need for accountability and answering. One of those colleagues has a great number of questions to answer about research involving Procter and Gamble. Honest answering is particularly important for a scientist, a very senior doctor and a previous Research Dean of a Medical School. Such individuals are held to a higher standard.

I am glad that Professor Eastell has had the good grace to admit to the false "findings" previously reported, the lie told to the Journal, and a little of the hidden data. The answering could however have been a little more straightforward, with less in the way of linguistic acrobatics. The scientific community has already demonstrated that it is not quite so easily diverted. The false publication should simply have been retracted (statistics and further publication to follow). And that was just the first of the three intended false publications.

With time I have become a dispassionate but interested observer of these events. There is a great deal to learn from them. The sad, almost desperate, attempts at obfuscation by others should be examined. Those attempts convey a great deal about the integrity and motives of regulators and leadership in medicine. It conveys how little respect we have for our patients who place themselves at risk to contribute to our "science". The events also convey a lot about way in which we deal with scientific misconduct when it involves considerable power. The system is kaput, bankrupt.

Character, they say, is like a fence. It can never be strengthened by whitewash, and it is a mistake to try. An apology might have been appropriate, and would certainly have helped a little.

"And sorry seems to be the hardest word
It's sad, so sad,
It's a sad, sad situation
And it's getting more and more absurd"
(Elton John)

09 April 2008
New Biomedical Units to put Sheffield at forefront of clinical research

The University of Sheffield, in partnership with Sheffield Teaching Hospital´s NHS Foundation Trust Sheffield, has been successful in its bid to develop two National Institute for Health Research (NIHR) Biomedical Research Units in musculoskeletal and cardiovascular disease.

The Biomedical Research Units will drive innovation in the prevention, diagnosis and treatment of ill-health and translate advances in medical research into benefits for patients.

They will be established in priority areas of disease, ill health and clinical need. Each unit will receive funding for four years with the first year drawing in £750k and £1m per year for the remaining three years (around $7.5 million)

The awards were made following bids by Professor Richard Eastell and Professor David Crossman from the University´s School of Medicine and Biomedical Sciences.

Professor Richard Eastell, Head of the Academic Unit of Bone Metabolism at the University of Sheffield and Honorary Consultant in the Metabolic Bone Centre at Sheffield Teaching Hospital´s NHS Trust, said: "We are delighted to have been successful in our application for this funding. This is a great boost to the Trust and the University.

"Having these two biomedical research units based in Sheffield is a major coup for the city and will firmly place us at the forefront of research.

"So many people will benefit from these units as they will enable us to be even stronger in these areas. This announcement is just the beginning, this is a wonderful opportunity for the city to shine.

Professor David Crossman, Head of Cardiovascular Science at the University and Honorary Consultant Cardiologist at Sheffield Teaching Hospital´s NHS Foundation Trust, said: "I am delighted with the investment in cardiovascular research in Sheffield. This will allow us the opportunity to launch new programmes of work designed at bringing our basic research to our patients with coronary artery disease."

Professor Tony Weetman, Dean of the School of Medicine and Biomedical Sciences at the University of Sheffield, said: "This is welcome news, which allows the University´s School of Medicine and Biomedical Sciences and the Trust to build on our successful partnership in translating research into medical practice for the benefit of patients.

"Our success in bidding for these prestigious NIHR Biomedical Research Units has been underpinned by our joint clinical research facilities, and I look forward to even closer working with the Trust as we develop the profile of academic medicine in Sheffield."

Andrew Cash, Chief Executive of Sheffield Teaching Hospitals NHS Foundation Trust, said: "This is a fantastic coup for Sheffield Teaching Hospitals and the University of Sheffield which will put the city firmly on the research map. We have an excellent ongoing relationship with the University and this is a further opportunity to extend that work for the benefit of patients in Sheffield and beyond."

For further information please contact: Jenny Wilson, Media Relations Officer on 0114 2225339 or email j.c.wilson@sheffield.ac.uk

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More great statistics from Procter and Gamble (Micro Statistics Tutorial 08)

Advertising Standards Authority (UK): 26 March 2008, Adjudication over Cat Food Advertisement (Iams Cat Food). More worthwhile statistics from Procter and Gamble:

The advertisements stated:

1. "Vets know catering to all your cats' different needs isn't easy ... 8 out of 10 vets recommend Iams
2. Voted No.1 recommended dry cat food brand available in supermarkets
3. Small print at the bottom of the ad stated "*Based on an independent survey of vets at the Congress of the British Small Animal Veterinary Association on complete dry cat foods available in supermarkets (April 2007)".

The Advertising Standards Authority noted that:

1. The survey asked vets if they would recommend any dry dog food, dry cat food or wet cat food brands. Only 31% of the participating vets (31% of 334) in fact recommended Iams.
2. Furthermore, the survey questions allowed participants to select a number of brands; they did not select only one brand.
3. Two other brands had more recommendations but these brands were available in pet food shops.
4. 80% of vets who recommended a brand of dry cat food available in supermarkets included Iams amongst the selection of products recommended, but not necessarily over those other products

Action: ASA told P&G to remove the claims "8 out of 10 vets" and "Voted No. 1 by vets" from future advertisements. The ASA did not comment on the irrelevancy of the survey (it should have surveyed cats), the nature of the sample, the post-hoc hypothesis, lack of any P value or who commissioned the "survey". For contaminated P&G catfood, see here.

Tutorial: Try to reconstruct the statistics from the ASA report.

See here for Collated Micro-Statistics Tutorials

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Princess Zetia and the pea

Is it a nugget for Zetia?

Or a pebble?

Or a pea?

Here is a bit of junk sounding research.

Or at least junk inferences drawn.

85 patients perhaps taking Zetia who improved compared to a "control" group
with different blood pressure control,
on (perhaps) a surrogate endpoint
in an underpowered study.

The study enrolled 499 Native American diabetics, half of whom were assigned to achieve LDL or bad cholesterol levels of 70 or lower while the others aimed for 100 or below.
The aggressive treatment group also aimed for systolic blood pressure readings of 115 compared to 130 for those assigned to standard of care.
About a third (perhaps) of the aggressively treated patients took Zetia (maybe 85 or so), but no one knows which.

Some got thick carotid artery walls and flabby ventricles. No clinical endpoints studied.

The dissection is continuing.

See Wall Street Journal Blog 9 April 2008: From ENHANCE to SANDS: A Nugget for Zetia?

See also

Pharmalot: Vytorin Prescriptions Will Plummet. Surprised?
Pharma Giles: Mr. Ten Percent... Redundancies at Scherigh Plough
Dr. Peter Rost: How does it feel to fire 5,000 employees, Mr. Hassan?

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